Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAP

A Phase 1, Randomized, Rater and Subject Blinded Placebo Controlled Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of a Standard and a Fractional Dose of H1 Influenza Vaccine Delivered by VX-103 (a MIMIX Microneedle Patch (MAP) System) in Healthy Adults ≥18-39 Years of Age

A Phase 1, Randomized, Rater and Participant Blinded Placebo Controlled Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of a Standard and a Fractional Dose of H1 Influenza Vaccine Delivered by VX-103 (a MIMIX Microneedle Array Patch (MAP) System) in Healthy Adults ≥18-39 Years of Age

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: H1 influenza antigen

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M9W 4L6
      • Centricity Research Toronto
  • Quebec
    • Mirabel, Quebec, Canada, J7J 2K8
      • Centricity Research Mirabel
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • Centricity Research Pointe-Claire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female aged 18 - 39 years inclusive
• Provide written informed consent to participate

• Healthy participants without acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality

  o As determined by medical history, physical exam, laboratory screening

• Body Mass Index 18-35 kg/m2, inclusive, at screening

Exclusion Criteria:

• Any medical condition that in the judgement of the investigator would make subject participation in the study unsafe.
• Having cancer or received treatment for cancer within three years (persons with a history of cancer who are disease-free without treatment for three years or more are eligible), excluding basal cell carcinoma (BCC) or squamous cell carcinoma (SCC), which are allowed unless located at the vaccination site.
• Impaired immune responsiveness (of any cause), including diabetes mellitus.
• Receipt or plan to receive a non-study vaccine within 30 days prior to vaccination or 60 days after vaccination.
• Receipt of any influenza vaccine in previous 24 months and/or planned receipt of influenza vaccine for the duration of the study.
• Diagnosed influenza infection in the previous 24 months prior to screening.
• Diagnosed COVID infection via medical personnel or at home test within the past 60 days prior to screening
• Allergy to influenza vaccine or components, or history of severe local or systemic reaction to any vaccination.
• History of anaphylactic type reaction to injected vaccines
• History of or current allergy to latex
• History of Guillain-Barré Syndrome.
• Positive test result for hepatitis B surface antigen (HBsAg,), hepatitis C virus antibody (HBcAb), or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening.
• History of chronic obstructive pulmonary disease or history of other lung disease.
• History of severe allergic reactions to eggs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 15 μg of the H1 influenza antigen	Biological: H1 influenza antigen; Either 7.5 μg or 15 μg of the H1 influenza antigen
Active Comparator: 7.5 μg of the H1 influenza antigen	Biological: H1 influenza antigen; Either 7.5 μg or 15 μg of the H1 influenza antigen
Placebo Comparator: Placebo (no antigen)	Biological: H1 influenza antigen; Either 7.5 μg or 15 μg of the H1 influenza antigen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the safety of VX-103 delivered as a single MIMIX MAP immunization	180 Days

Collaborators and Investigators

• Sponsor: Vaxess Technologies
• Collaborators: ICON plc; Q2 Solutions; Centricity Research

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2022
• Primary Completion (Actual): March 13, 2023
• Study Completion (Actual): March 13, 2023

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Estimated): November 9, 2023

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: VX-103-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No